LIVE FROM Pharma EXPO: Addressing single-use concerns

‘Don’t be afraid of the dark’ when implementing single-use, says one operations expert at Pharma EXPO Conference Program.

LIVE FROM Pharma EXPO: Addressing single-use concerns
LIVE FROM Pharma EXPO: Addressing single-use concerns

When considering single-use implementation, “There is light at the end of the tunnel,” explains Jeff Odum, Director of Operations, Integrated Project Services, Inc.

As single-use technology becomes more widely adopted, it’s usually the benefits that receive all the attention, but it does bring challenges as well. In his presentation, “Single Use Systems: Explore the Manufacturing Impact from Supplier Qualification to Optimizing Operations,” Odum shed some light on four main single-use concerns keeping manufacturers up at night:

• Operability—teaching old dogs in the workforce new tricks

• System closure—determining how closed is “closed”

• Leak concerns—validating the integrity of the closure

• Supply chain quality and control—minimizing risk with increased inventory

Odum noted that single use requires more operator interaction than facilities (which have focused on automation) have become accustomed to, and that rather than purging the workforce, it’s important to provide robust training to refocus the efforts of talented personnel. On a related note, limiting operator handling of bags is key to minimizing leaks caused by tears in single-use systems.

Single-use tube sets can cause inventory requirements to increase dramatically, so it’s important to evaluate how often a certain tube set is used, how complex it is, and how it’s packaged. Odum explains, “Depending on the number of components of a tube set, unpacking, inspecting, and hooking it up in the area can be quite time-consuming.” Ultimately, companies must determine whether single use is right for their needs and develop a strategy for implementation that includes training.

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